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split-mouth RCT, 25 months follow up. GBR protocol with LPRF as grafting material in the test group and autogenous bone with DBBM as grafting material in the control group.
6 patients were included in this split-mouth RCT. In control sites a horizontal GBR procedure was performed using a titanium reinforced dPTFE membrane with a graft consisting of 50% autogenous bone and 50% DBBM. In test sites a titanium reinforced dPTFE membrane was used, with a graft consisting of an LPRF block. This was left to heal for 9 months. Subsequently an implant was placed. At time of implant placement a bone biopsy was taken. After 4 months of osseointegration the abutment connection was performed. 1 year after loading of the implants a final check was done. CBCT scans were taken at intake, immediately after reconstruction, 9 months after reconstruction, before implant placement and 1 year after loading of the implants.
Primary outcome measure is the bone volume as measured on the CBCT scans. Secondary outcome measures are bone quality in the biopsy, buccal bone thickness around the oral implant, number and type of complications, cumulative survival rates of the implants 1 year after loading.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | LPRF block as a grafting material |
|
| Control | Experimental | 50% autogenous bone, 50% DBBM as a grafting material |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| guided bone regeneration | Procedure | a non-resorbable membrane was used as a space maintainer, filled with a particulated bone graft. |
|
| Measure | Description | Time Frame |
|---|---|---|
| bone volume as measured on CBCT scans | CBCT scans taken and software used for measurement | CBCT scans at intake, with follow-up until 25 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Buccal bone thickness around the implants | Bone thickness measured on CBCT scans | CBCT scans at placement of the implant and 1 year after loading of the implant |
| Buccal bone thickness around the implants |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
all info available on request
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split-mouth 2 arm RCT
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neither the patient, nor the outcome assessor was aware at which side which grafting material was used
Bone thickness measured on CBCT scans
| CBCT scans at 1 year after loading of the implant |
| Cumulative survival rate of the implants | Implants followed for 1 year after loading and survival recorded | 16 months of follow-up |
| rates and types of complications | All complications recorded during 25 months follow-up | 25 months |